Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Director, Regulatory Affairs - Immuno-Oncology

  • Jan 2023 - Present

  Tarrytown, New York, United States

• Associate Director Regulatory Affairs - Immuno-Oncology

  • Jan 2021 - Dec 2022

  • Global regulatory lead for early and late-stage development programs of bispecific antibodies (BsAb) in B-cell lymphoma. Accountable for developing and implementing global registration strategy in lymphoma for US, EU, China, and Japan. • Leading the original BLA submission activities for a novel BsAb for 2 indications in B-cell lymphoma simultaneously. Initiated the preparation of a potential REMS based on regulatory risk assessment. • Led FDA meetings for 3 novel BsAbs throughout… Show more • Global regulatory lead for early and late-stage development programs of bispecific antibodies (BsAb) in B-cell lymphoma. Accountable for developing and implementing global registration strategy in lymphoma for US, EU, China, and Japan. • Leading the original BLA submission activities for a novel BsAb for 2 indications in B-cell lymphoma simultaneously. Initiated the preparation of a potential REMS based on regulatory risk assessment. • Led FDA meetings for 3 novel BsAbs throughout clinical development, including 2 Type A, 5 Type B, and 2 Type C meetings. • Led FDA pre-BLA meeting and reached agreement with FDA on the proposed data package for 2 indications. • Represented regulatory in due diligence process for collaboration deal and worked with the collaboration partner (Zai Lab) to develop registration strategy in China. • Led the preparation and FDA teleconferences for 4 preliminary Breakthrough Therapy Designation Advice Requests for 2 indications and gained agreement on the path of submitting a formal BTD. • Provided strategic input and participated in EMA scientific advice meetings, EMA pre-submission meetings (PIP and orphan drug designations), EMA oral explanation, and China CDE written-response-only meeting. • Chaired the regulatory subteams for assigned molecules to ensure the subteam outputs support the corporate goals. • Applied innovative regulatory approaches to expedite clinical development, including the use of a novel validated surrogate endpoint, real-world data, joint meeting with EMA/FDA, and parallel submissions of EU PIP and US iPSP. • Initiated oncology dose optimization cross-functional working group in response to FDA’s Project Optimus and defining a framework for oncology study designs. • Experience in managing direct reports.

• Senior Manager Regulatory Affairs - Immuno-Oncology

  • Jan 2020 - Dec 2020

  Tarrytown, New York, United States From Aug 2017 - Dec 2020: • Global regulatory lead for early and late-stage development programs of bispecific antibodies (BsAb) in hematologic malignancies, including B-cell lymphoma and multiple myeloma. • Drove and led a parallel scientific meeting with EMA and FDA to discuss the pediatric study design for a BsAb in B-cell lymphoma which led to the agreed US iPSP and EU PIP prior to BLA and MAA submissions. • Led the submission of 2 original INDs for 2 BsAbs to enable respective… Show more From Aug 2017 - Dec 2020: • Global regulatory lead for early and late-stage development programs of bispecific antibodies (BsAb) in hematologic malignancies, including B-cell lymphoma and multiple myeloma. • Drove and led a parallel scientific meeting with EMA and FDA to discuss the pediatric study design for a BsAb in B-cell lymphoma which led to the agreed US iPSP and EU PIP prior to BLA and MAA submissions. • Led the submission of 2 original INDs for 2 BsAbs to enable respective first-in-human studies. Successfully addressed FDA’s safety concerns for this class of molecules and received study may proceed letters. • Led and oversaw the global submission of CTAs to EU and APAC countries, including China and Japan to start the registration studies. • Led the team to obtain US Orphan Drug designations and Fast Track Designations for 2 indications, respectively. Provided strategic input for obtaining EU Orphan Drug designations for 2 indications. • Led the team to prepare comprehensive data packages to address FDA clinical deficiency comments which led to the removal of 4 clinical holds. Extensive experience in addressing global health authorities’ requests due to the safety concerns for this class of molecules. • Chaired the regulatory subteams for assigned molecules to ensure the subteam outputs support the corporate goals. • Drove and obtained International Nonproprietary Name (INN) and United Sates Adopted Name (USAN) for a late-stage bsAb.

• Manager, Regulatory Affairs - Immuno-Oncology

  • Aug 2017 - Dec 2019

  Greater New York City Area



Medivation

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Associate, Regulatory Affairs - Oncology

  • Mar 2016 - May 2017

  San Francisco Bay Area • Supported the clinical development program of a PARP inhibitor, talazoparib, in ovarian cancer, breast cancer, and prostate cancer. • Led the FDA Type C Written-Response Only meeting to discuss the talazoparib clinical pharmacology program and gained alignment on the package to support the NDA submission for talazoparib in breast cancer. • Coordinated the development and submission of an IND for talazoparib to enable the phase 2 pivotal study in ovarian cancer. Received study may… Show more • Supported the clinical development program of a PARP inhibitor, talazoparib, in ovarian cancer, breast cancer, and prostate cancer. • Led the FDA Type C Written-Response Only meeting to discuss the talazoparib clinical pharmacology program and gained alignment on the package to support the NDA submission for talazoparib in breast cancer. • Coordinated the development and submission of an IND for talazoparib to enable the phase 2 pivotal study in ovarian cancer. Received study may proceed letter within 30-day review. • Coordinated the authoring and review of health authority meeting packages to discuss the clinical development program of talazoparib and companion diagnostics, including FDA Type B Meeting Package, EMA scientific advice briefing book, and FDA Risk Determination Request. • Led the global submission of CTAs to EU, South America, and APAC countries to start phase 1 and phase 2 studies. • Performed regulatory intelligence research for approvable primary endpoints in ovarian cancer to support the registrational study design. • Led the development of standard operating procedures for CTA submission and internal communication plans for CTA submission and approval. • Participated in the Regulatory Intelligence Forum and collaborated with key stakeholders to develop company-wide Regulatory Intelligence Newsletters. Show less



BioMarin Pharmaceutical Inc.

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate II, Regulatory Affairs - Rare Pediatric Disease

  • Aug 2015 - Feb 2016

  San Francisco Bay Area • Supported US and EU marketing application activities for a gene therapy, drisapersen, to treat Duchenne Muscular Dystrophy. • Led the authoring and review of the responses to FDA information requests during NDA review. Responded to 25 rounds of FDA requests within 3 months; some with same day turnaround. • Supported the PCNS advisory committee meeting briefing book and participated in rehearsals. • Drafted and submitted the Rare Pediatric Disease Priority Review Voucher request… Show more • Supported US and EU marketing application activities for a gene therapy, drisapersen, to treat Duchenne Muscular Dystrophy. • Led the authoring and review of the responses to FDA information requests during NDA review. Responded to 25 rounds of FDA requests within 3 months; some with same day turnaround. • Supported the PCNS advisory committee meeting briefing book and participated in rehearsals. • Drafted and submitted the Rare Pediatric Disease Priority Review Voucher request. • Supported the EMA inspection activities for 3 clinical sites for EU MAA. • Performed regulatory intelligence research on the precedence of orphan drug approvals based on randomized withdrawal study design. • Managed the submissions of amendments to US IND and ex-US CTAs for ongoing and planned clinical trials. Show less



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• Intern, Clinical Regulatory Affairs-Immuno-Oncology

  • Jul 2014 - Jul 2015

  San Francisco Bay Area • Supported the clinical development program of a PD-L1 inhibitor, atezolizumab in lung cancer. • Coordinated the preparation of 3 FDA meetings for 6 phase 3 RCTs in non-small cell lung cancer and small cell lung cancer within 3 months, including the development of briefing books, responses to preliminary comments, development of Q&A document, and rehearsals. • Supported the study start-up activities for 6 Phase 3 lung cancer studies and maintained multiple atezolizumab INDs for ongoing… Show more • Supported the clinical development program of a PD-L1 inhibitor, atezolizumab in lung cancer. • Coordinated the preparation of 3 FDA meetings for 6 phase 3 RCTs in non-small cell lung cancer and small cell lung cancer within 3 months, including the development of briefing books, responses to preliminary comments, development of Q&A document, and rehearsals. • Supported the study start-up activities for 6 Phase 3 lung cancer studies and maintained multiple atezolizumab INDs for ongoing phase 1-3 studies. • Performed regulatory intelligence research to inform the BLA submission strategy for atezolizumab in lung cancer and bladder cancer. • Participated in Companion Diagnostic workstream to develop educational materials for the regulatory department. Show less



Association for Women in Science

• United States
• Civic and Social Organizations
• 1 - 100 Employee

• Vice President

  • Aug 2013 - Jun 2015

  San Francisco Bay Area •Teamed with the program committee to develop topics for monthly meetings and actively collaborated with biotech industry leaders to host career seminars focused on life sciences •Planned, organized, and facilitated the monthly meetings, including recruiting speakers, coordinating speakers’ schedules and moderating the panel discussion



University of California, San Francisco

• United States
• Higher Education
• 700 & Above Employee

• Postdoctoral Fellow

  • Apr 2012 - Jun 2014

  San Francisco Bay Area •Identification and Functional analyses of a novel transcript isoform that is highly expressed in patients with lung adenocarcinoma •Managed and led a team of two in development of biomarker assays for lung cancer in various platforms, including qPCR, FISH, and ELISA •Assisted lab manager in managing budgets and developing training programs for new instruments •Prepared grant progress reports to the funding agencies •Training in Ion Torrent/Ion Proton Next-Generation Sequencer and… Show more •Identification and Functional analyses of a novel transcript isoform that is highly expressed in patients with lung adenocarcinoma •Managed and led a team of two in development of biomarker assays for lung cancer in various platforms, including qPCR, FISH, and ELISA •Assisted lab manager in managing budgets and developing training programs for new instruments •Prepared grant progress reports to the funding agencies •Training in Ion Torrent/Ion Proton Next-Generation Sequencer and Ingenuity IPA Pathway Analysis Show less



Stony Brook University

• United States
• Higher Education
• 700 & Above Employee

• Postdoctoral Associate/PhD Student

  • Aug 2005 - Oct 2011

  Stony Brook, NY •Identified novel functions for a highly conserved cell cycle kinase, Cdc7, in chromosome segregation and transcriptional regulation during budding yeast meiosis which lead to two first author publications •Developed and published a protocol for labeling direct substrates for meiosis-specific kinases in vivo •Contributed to the funding of two NIH R01 research grants by generating preliminary results •Delivered oral presentations at annual multidisciplinary seminar series, lab… Show more •Identified novel functions for a highly conserved cell cycle kinase, Cdc7, in chromosome segregation and transcriptional regulation during budding yeast meiosis which lead to two first author publications •Developed and published a protocol for labeling direct substrates for meiosis-specific kinases in vivo •Contributed to the funding of two NIH R01 research grants by generating preliminary results •Delivered oral presentations at annual multidisciplinary seminar series, lab meetings, department retreats and international conferences •Coached and instructed undergraduate and graduate students in research and laboratory techniques Show less